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Simplified Prognostic Model in Patients with Oxaliplatin-Based or Irinotecan-Based First-Line Chemotherapy for Metastatic Colorectal Cancer: A GERCOR Study

机译:基于奥沙利铂或伊立替康的一线化疗对转移性结直肠癌患者的简化预后模型:GERCOR研究

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Background. The present study was done to establish a prognostic model for patients and trials using an oxaliplatin-based or irinotecan-based first-line chemotherapy in metastatic colorectal cancer. Patients and Methods. Eight hundred three patients treated with FOLFOX or FOLFIRI in three prospective trials were randomly separated into learning (n = 535) and validation (n = 268) samples. Eleven baseline variables were evaluated in univariate and multivariate analysis as prognostic factors for overall survival, and a prognostic score was developed. Results. Independent prognostic factors identified in multivariate analysis for overall survival were performance status (PS) (p .001), serum lactate dehydrogenase (LDH) (p .001), and number of metastatic sites (p = .005). A prognostic score based on these three variables was found efficient (Harrell's C index 0.61). This new model was improved by selecting only PS and LDH (Harrell's C index 0.64). Three risk groups for death could be identified: a low-risk group (n = 184; median overall survival [OS] 29.8 months), an intermediate-risk group (n = 223; median OS 19.5 months), and a high-risk group (n = 128; median OS 13.9 months). Median survival for the low-, intermediate-, and high-risk groups were 26.8, 21.1, and 16.5 months, respectively, in the validation sample (Harrell's C index 0.63). Conclusions. Serum LDH level was the main prognostic factor in predicting survival, followed by WHO PS. We identified three risk groups for death depending on these two baseline parameters. This simple prognostic model can be useful for clinician's use and patient stratification in future clinical trials.
机译:背景。本研究旨在为转移性结直肠癌使用基于奥沙利铂或基于伊立替康的一线化疗的患者和试验建立预后模型。患者和方法。在三项前瞻性试验中,用FOLFOX或FOLFIRI治疗的803名患者被随机分为学习样本(n = 535)和验证样本(n = 268)。在单变量和多变量分析中评估了11个基线变量作为整体生存的预后因素,并制定了预后评分。结果。在多因素分析中确定的总生存期的独立预后因素是表现状态(PS)(p <.001),血清乳酸脱氢酶(LDH)(p <.001)和转移部位的数量(p = .005)。发现基于这三个变量的预后评分有效(Harrell's C指数0.61)。通过仅选择PS和LDH(Harrell的C指数0.64)改进了此新模型。可以确定死亡的三个风险组:低风险组(n = 184;中位总生存期[OS] 29.8个月),中度风险组(n = 223;中位OS 19.5个月)和高风险组(n = 128;中位OS 13.9个月)。在验证样本中,低风险,中风险和高风险组的中位生存期分别为26.8、21.1和16.5个月(Harrell C指数为0.63)。结论。血清LDH水平是预测生存的主要预后因素,其次是WHO PS。根据这两个基线参数,我们确定了三个死亡风险组。这种简单的预后模型对于临床医生的使用和将来的临床试验中的患者分层很有用。

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